Euro Roundup: European Commission greenlights Med4Cure project
The European Commission (EC) approved up to 1 billion Euros (US $1.08 billion) of state aid for the first Important Project of Common European Interest (IPCEI), known as Med4Cure. The initiative aims to accelerate drug discovery, especially in rare diseases, and develop sustainable pharmaceutical production processes.The project was jointly notified by EC member states Belgium, France, Hungary, Italy, Slovakia and Spain. An additional 5.9 billion Euros (US $6.4 billion) is expected from private investments.
Overall, 13 companies within the member states are expected to launch 14 innovative projects over the initiative's lifetime.
Med4Cure participants will focus on four key areas:
- Developing a network of biobanks to identify drugs and diagnostic candidates
- Developing pre-clinical models to test novel therapies and diagnostics
- Validating new therapies
- Developing sustainable technologies for pharmaceutical production
“Med4Cure will support breakthrough innovations in the health space. It focuses on developing treatments for so-called ‘orphan’ diseases, which affect fewer than 1 in 2,000 people,” EC Executive Vice President Margrethe Vestager said in a speech. “It will also address emerging health threats such as antimicrobial resistance, where antibiotics no longer work and new treatments are needed. And it will also ensure that the European pharmaceutical sector is at the forefront when it comes to digitalization and sustainability.”
While individual timelines will vary, the completion of the overall initiative is planned for 2036.
Press Release, Speech
MDCG revises device surveillance guidance
The Medical Device Coordination Group (MDCG) issued a second revision to its guidance on appropriate surveillance for medical devices. The latest set of changes includes adjustments to align the guidance with EU regulations related to transitional provisions for certain medical devices and in vitro diagnostic medical devices (IVDs).
The document covers the transitional provisions under Article 120 of the Medical Device Regulation (MDR) related to devices covered by certificates under the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD).
The guidance states that appropriate surveillance only applies to legacy devices covered by a certificate issued under MDD or AIMDD. Legacy devices are not subject to appropriate surveillance under Article 120 if the conformity assessment procedure under the MDD did not require the involvement of a notified body, even if involvement of the notified body is required under the MDR.
Additionally, if the notified body that issued either the MDD or AIMDD certificate is not designed under the MDR, the responsibility for appropriate surveillance will end on 25 September 2024. After that, appropriate surveillance is the responsibility of the notified body with which the manufacturer has signed the written agreement for MDR certification.
Revised Guidance
EFPIA touts importance of regulatory data protection
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new data highlighting the importance of regulatory data protection (RDP) and pushing back on legislative proposals to reduce the RDP baseline.
EFPIA commissioned Copenhagen Economics to examine the impact of spending 1.23 billion Euros (US $1.3 billion) per year in the EU on an additional year of RDP (at the EU and member state level) and the potential impact of reducing the RDP duration on innovation.
The Copenhagen Economics data revealed that across 27 Member States, the 1.23 billion Euro expenditure would represent 0.07% of overall healthcare spending in the EU and 0.51% of pharmaceutical spending each year.
“The data reaffirms previous studies – using different and multiple methodologies – that under the European Commission’s proposals, the EU would stand to lose around 2 billion Euros in global R&D investment across the 27 Member states every year,” Nathalie Moll, EFPIA Director General, said in a statement.
Press Release
Swissmedic: Project Orbis accelerates access to cancer treatment
An analysis by the Swiss Agency for Therapeutic Products (Swissmedic) found that participation in Project Orbis – a collaboration with the US Food and Drug Administration (FDA) to provide parallel advice on oncology marketing authorizations – has reduced submission and review times and increased the consistency of approval decisions between the two agencies.
Swissmedic joined Project Orbis in 2020 and the analysis reviews the impact of the program during the first 2 years. Investigators at Swissmedic and Geneva University Hospital examined authorization decisions and approved indications across Swissmedic and FDA, both in and out of Project Orbis. The findings were published in The Lancet Oncology.
The time between the date of submission to FDA and Swissmedic was 33 days for Project Orbis applications, compared with 168 days for applications outside of the project. Review times at Swissmedic were also shorter for Project Orbis applications: 235.5 days versus 314 days. The findings also suggested that Project Orbis encouraged greater agreements between the two agencies. For applications for new active substances, Swissmedic and FDA decisions were identical for 88% of Project Orbis applications, compared with 82% of non-Project Orbis applications.
Press Release, Lancet Oncology article
Fimea updates instructions on submitting patient data to EVPM
The Finnish Medicines Safety and Development Center (Fimea) recently updated instructions for marketing authorization holders to submit patient data in adverse reaction reports to the EudraVigilance Post-authorisation Module (EVPM) database. The change allows marketing authorization holders to potentially limit the personal data reports to the database.
Fimea advised that decisions on how much personal data to report could be made on a “case-by-case basis” if the submission is complete enough to make it possible to identify duplicate reports.
The agency said it will update the instructions for submitting personal data if these changes complicate pharmacovigilance and the processing of adverse reaction reports.
Press Release
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